U.S. patent number 7,815,629 [Application Number 11/191,449] was granted by the patent office on 2010-10-19 for apparatus for treating obesity by extracting food.
This patent grant is currently assigned to DEKA Products Limited Partnership. Invention is credited to David E Altobelli, Michael Ambrogi, Dean Kamen, Samuel Klein, Moshe Shike, Stephen B Solomon, Eric Yeaton.
United States Patent |
7,815,629 |
Klein , et al. |
October 19, 2010 |
Apparatus for treating obesity by extracting food
Abstract
The present invention is directed to an apparatus and method for
treating obesity. A tube is positioned that passes through a
patient's abdominal wall into the upper digestive system of the
patient. The patient is allowed to carry out his/her everyday
affairs including ingesting food. After the patient has ingested
food, the food is extracted by pumping it out of the upper
digestive system through the tube. The present invention is less
invasive than current surgical procedures for reducing weight and
allows patients to live a normal and active lifestyle without
experiencing adverse side effects.
Inventors: |
Klein; Samuel (Clayton, MO),
Solomon; Stephen B (New York, NY), Shike; Moshe
(Larchmont, NY), Kamen; Dean (Bedford, NH), Ambrogi;
Michael (North Hampton, NH), Altobelli; David E (Hollis,
NH), Yeaton; Eric (Epsom, NH) |
Assignee: |
DEKA Products Limited
Partnership (Manchester, NH)
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Family
ID: |
46304895 |
Appl.
No.: |
11/191,449 |
Filed: |
July 27, 2005 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20050277900 A1 |
Dec 15, 2005 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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10702194 |
Nov 4, 2003 |
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60423645 |
Nov 4, 2002 |
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60600496 |
Aug 10, 2004 |
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60618346 |
Oct 12, 2004 |
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Current U.S.
Class: |
604/540; 604/332;
604/355 |
Current CPC
Class: |
A61M
1/842 (20210501); A61F 5/004 (20130101); A61F
5/003 (20130101); A61M 1/84 (20210501); A61M
1/81 (20210501); A61M 27/002 (20130101); A61M
1/82 (20210501); A61F 5/0076 (20130101); A61J
15/0015 (20130101); A61F 2002/044 (20130101); A61M
25/04 (20130101); A61M 1/0023 (20130101); A61M
1/0062 (20130101); A61M 2210/1053 (20130101) |
Current International
Class: |
A61M
1/00 (20060101); A61F 5/44 (20060101) |
Field of
Search: |
;604/318,319,540,909,332,355 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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1 374 930 |
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Jan 2004 |
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EP |
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62-224358 |
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Oct 1987 |
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JP |
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3-18378 |
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Jan 1991 |
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JP |
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200129434 |
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Feb 2001 |
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JP |
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WO 94/15655 |
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Jul 1994 |
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WO |
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WO 99/25418 |
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May 1999 |
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WO |
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WO 01/68007 |
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Sep 2001 |
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WO |
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Other References
Moshe Shike, MD et al., An Active Esophageal Prothesis,
Gastrointestinal Endoscopy Jan. 1995 vol. 41 No. 1. cited by other
.
Lawerence L. Herman, MD et al., Percutaneous endoscopic gastrostomy
for decompression of the stomach and small bowel, Gastrointestinal
Endoscopy, 1992 pp. 314-318. cited by other .
Joshau Felsher,M.D et al., Decompressive percutaneous endoscopic
gastrotomy in nonmalignant disease, The American Journal of Surgery
187 (2004) 254-256. cited by other .
Henry Buchwald, MD et al., Bariatric Surgery, a Systematic Review
and Meta-Analysis, JAMA, Oct. 13, 2004--vol. 292, No. 14. cited by
other .
Meissner K. Hepatogastroenterology. Mar.-Apr. 2004;51(56):462-4.
Ajuvant surgical decompression gastrostomy: audit of a procedure
coming of age. cited by other .
Michaud L et al., J Pediatr Gastroenterol Nutr. Jan. 2001;
32(1):82-5, Gastrostomy as a decompression technique in children
with chronic gastrointestinal obstruction. cited by other .
Herman LL et al., Gastrointest Endosc. May-Jun. 1992; 38 (3):
314-8, Percutaneous endoscopic gastrostomy for decompression of the
stomach and small bowel. cited by other .
Shike M., Oncology (Huntingt). Jan. 1995:9(1):39-44; discussion 44,
Percutaneous endoscopic stomas for enteral feeding and drainage.
cited by other .
Shike M et al., JPEN J Parenter Enteral Nutr. Nov.-Dec.
1989;13(6):648-50. Skin-level gastrostomies and jejunostomies for
long-term enter feeding. cited by other .
Nassif AC. Obes Surg. Mar. 1991;1(1):99-102., Efficient
Decompression and Immediate Enteral Hyperaliment via Gastrostomy as
an Adjunct to Gastroplasty. cited by other .
Shike M, Gastrointest Endosc. May-Jun. 1990:36(3):290-2. Combined
gastric dranage and jejunal feeding through a percutaneous
endoscopic stoma. cited by other .
Moseh Shike, MD et al. External biliary duodenal drainage through a
percutaneous endoscopic duodensotomy, Gastrointestinal Endoscopy,
vol. 35, No. 2, 1989. cited by other .
Moshe Shike, MD et al., Percutaneous endoscopic gastrostomy and
jejunostomy for long-term feeding in patients with cancer of the
head and neck, otolaryngology Head and Neck Surgery vol. 101 (5),
1989. cited by other .
T. Lorentzen et al., Percutaneous Gastrostomy guided By Ultrasound
and Fluorscopy ACTA Radiologica 36 (1995) 159-162. cited by other
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Francesco Doenz et al., Versatility of the Proximal Cope Loop
Catheter, American Journal of Roentgenolog Jan. 1989, 205. cited by
other .
K.E. Gehman et al. Percutaneous Gastrojejunostomy with a Modified
Cope Loop Catheter, American Journal of Roentgenology 155.79-80
(1990). cited by other .
Robin R. Gray, MD, et al., Modified Catheter For Percutaneous
Gastrojejunostomy Radiology 1989; 173:276-278. cited by other .
Richard Duszak, Jr. MD, Percutaneous Gastrostomy and Jejunostomy
http.//www.emedicine.com/radio/topic798.htm (Jul. 8, 2005). cited
by other .
Katherine M. Flegal, PhD et al. Prevalence and Trends in Obesity
Among US Adults, 1999-2000 JAMA, Oct. 9, 2002 vol. 288, No. 14,
1723-1727. cited by other .
Andrew Luck and Peter Hewett Lapraoscopic Gastrostomy: Towards The
Ideal Technique Aust. N.Z. J. Surg. (1998) 68,281-283. cited by
other .
F.J. Thornton et al., Percutaneous Radiologic Gastrostomy With and
Without T-Fastener Gastropexy: A Randomized Comparison Study
CardioVascular Interventional Radiology (2002) 25:467-471. cited by
other .
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of Radiology 43 (2002) 186-195. cited by other .
Goldstein DJ., Beneficial health effects of modest weight loss, Int
J Obes 1992 16:397-415. cited by other.
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Primary Examiner: Hand; Melanie J
Attorney, Agent or Firm: Proskauer
Parent Case Text
RELATED APPLICATIONS
This application is a continuation-in-part application of U.S.
patent application Ser. No. 10/702,194, filed Nov. 4, 2003, now
abandoned which claims the benefit of U.S. Provisional Application
No. 60/423,645, filed Nov. 4, 2002, each of which is incorporated
by reference herein. This application claims priority to U.S.
Provisional Application No. 60/600,496, filed Aug. 10, 2004 and
U.S. Provisional Application No. 60/618,346, filed Oct. 12, 2004,
each of which is incorporated by reference herein.
Claims
We claim:
1. An apparatus comprising: a. a tube comprising i. a distal end
portion having a sidewall with a plurality of holes located
therein, wherein said holes are sized and configured to facilitate
drainage of food from the upper digestive system of a patient and
out through the tube; and ii. a proximal end portion that is
configured to pass through the patient's abdominal wall when the
distal end portion of the tube is disposed in the upper digestive
system of the patient; b. a first retention member attached to the
tube to prevent dislodgement of the tube; and c. a morcellation
device at the distal end portion of the tube to grind and divide
food into smaller pieces as the food enters the tube.
2. The apparatus of claim 1, wherein the morcellation device
comprises a mechanical propeller and a housing or cage surrounding
the propeller to protect body tissue from the propeller.
3. The apparatus of claim 1, wherein the first retention member is
configured with respect to the tube so that the proximal end
portion of the tube will lie substantially flush with the patient's
abdominal surface when the distal end portion of the tube is
disposed in the upper digestive system of the patient.
4. The apparatus of claim 1, further comprising a pump that is
attachable or permanently attached to the tube for removing food
from the upper digestive system of the patient.
5. The apparatus of claim 4, wherein the tube further comprises a
luer lock configured so that the pump is attachable or permanently
attached to the tube's outer surface.
6. The apparatus of claim 1, further comprising a housing or cage
surrounding the distal end portion of the tube to prevent gastric
mucosa from being sucked into the holes.
Description
BACKGROUND OF THE INVENTION
Obesity is a major health problem in the United States and other
countries. The National Health and Nutrition Examination Survey
(1988-1994) reported that approximately 20-25% of Americans are
obese, while another study estimated the percentage of overweight
Americans to be between 60% and 65% (Flegal K M, Carroll M D, Ogden
C L, Johnson C L "Prevalence and trends in obesity among US adults,
1999-2000" JAMA 2002; 288:1723-1727). Obesity can cause numerous
health problems, including diabetes, degenerative joint disease,
hypertension, and heart disease. Weight reduction can be achieved
by increased caloric expenditure through exercise and/or by reduced
caloric consumption through diet. However, in most cases, weight
gain often recurs and improvements in related co-morbidities are
often not sustained.
Surgical procedures present an increasingly common solution for
obese patients. Surgical procedures include, for example, stapled
gastroplasty, banded gastroplasty, gastric banding, gastric bypass
surgery, and bilopancreatic bypass. However, these surgical
procedures are invasive, risky and expensive to perform, and many
patients regain a substantial portion of the lost weight.
SUMMARY OF THE INVENTION
The present invention is directed to apparatuses and methods for
treating obesity or facilitating weight loss. A passageway is
introduced into a patient's upper digestive system such that it
passes through the patient's abdominal wall. The patient is allowed
to carry out his/her everyday affairs including ingesting food.
After the patient has ingested food, the food is extracted by
pumping it out of the upper digestive system through the
passageway. This approach is less invasive than the procedures
discussed above, easy to perform, easy to reverse and has
successfully resulted in significant weight loss in obese
patients.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic view of a first embodiment of the present
invention installed in a patient;
FIG. 1A is a schematic view of a tube;
FIG. 1B is an alternate view of a tube;
FIG. 1C is a cross sectional schematic view of a tube;
FIG. 2 is a schematic view of a variation of an embodiment of the
present invention that uses a manual bulb pump;
FIG. 3 is a schematic view of a variation of an embodiment of the
present invention that uses a syringe as a pump;
FIG. 4 is a schematic view of a variation of an embodiment of the
present invention that uses a bag connected to a pump;
FIG. 5 is a schematic view of how an embodiment of the present
invention can be cleaned;
FIG. 6 is a schematic view of a second embodiment of the present
invention that uses an inflated balloon anchor;
FIG. 7 is an axial cross sectional schematic view showing valves
provided in the lumens of a tube in an embodiment of the present
invention;
FIG. 8 is a schematic view of a third embodiment of the present
invention having a tube with two balloons attached to that portion
of the tube that is disposed within the patient's digestive
system;
FIG. 9 is a schematic view of a fourth embodiment of the present
invention having a tube with a curved configuration and a plurality
of holes in a sidewall;
FIG. 10 is a schematic view of a fifth embodiment of the present
invention having a tube with a curved configuration, multiple holes
in a sidewall, and a morcellation device housed within a cage at
its distal end portion;
FIG. 11 is a schematic view of the proximal end portion of a tube
lying substantially flush with a patient's abdominal wall;
FIG. 12 is a schematic view of a luer lock at the proximal end
portion of a tube;
FIG. 13 is a schematic view of a variation of an embodiment of the
present invention having a tube with a funnel shaped tip;
FIG. 14 is a schematic view of a sixth embodiment of the present
invention having two intake tubes;
FIGS. 15A and FIG. 15B are schematic views of an embodiment of the
present invention installed in a patient illustrating how the
apparatus accommodates changes in thickness of the abdominal wall
of a patient;
FIG. 16 illustrates how an embodiment of the present invention
installed in a patient is used.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
As used herein, the term "food" includes both solid and liquid
substances that have been ingested by the patient, the term
"ingest" or "ingested" includes eating and drinking, and the term
"upper digestive system" includes the stomach 3, duodenum 4 and
proximal jejunum of the patient.
In a first embodiment of the present invention as shown in FIG. 1,
a transabdominal tube 1 is placed through a patient's abdominal
wall such that a distal end portion 17 of the tube 1 is disposed
inside the stomach 3 of the patient and a proximal end portion 16
of the tube 1 extends out from the skin 5 of the patient. The tube
1 preferably has a diameter that is 20 to 36 French in size (1
French=1/3 mm). Most preferably, the diameter is greater than 28
French and the tube resists collapsing when extraction is
performed. Optionally, the tube 1 may be stiffened, made durable
and less collapsible by, for example, braiding the tube using
nylon. Alternatively, the tube may be wrapped with wire material.
Suitable materials for the tube 1 include polyurethane, silicone
and other similar materials. The tube 1 may be opaque.
A retention member is attached to the tube 1 to prevent the tube 1
from falling out of the patient. In one embodiment, the retention
member is inflatable such as the inflation portion 2 (balloon
anchor) shown in FIG. 1. As shown in FIG. 1, the inflation portion
2 is provided at the distal end portion 17 of the tube 1 to prevent
the tube 1 from coming out of the stomach 3. FIG. 1 also
illustrates a non-inflatable retention member flange 2' at the
proximal end portion 16 of the tube 1 to prevent the tube 1 from
falling into the patient's upper digestive system. A cap 13 is
detachably provided at the end of the proximal end portion 16 and
seals the tube 1 when it is attached. The cap 13 is removed when a
pump 8, 9 (shown in FIGS. 2 and 3, respectively) is attached to the
tube 1 to remove food from the upper digestive system of the
patient.
Reference is now made to methods which may be used to insert the
tube 1. These methods entail less risk of complications and less
cost than conventional, surgical methods of treating obesity, and
patients who undergo these treatments are typically discharged the
same day of the operation. These methods are therefore especially
advantageous for use in treating obese patients because such
patients are at increased risk for surgical complications due to
their obesity.
The tube 1 may be inserted, for example, through a procedure
similar to insertion of feeding tubes by Percutaneous Endoscopic
Gastrostomy (PEG). A variety of methods of performing PEG are well
known in the art, and any one of the methods may be used to insert
the tube 1. PEG procedures have been successfully completed in over
90 percent of attempts. PEG may be performed under conscious
sedation induced by, for example, meperidine and midazolam.
According to one method of PEG known as the pull method, an
endoscope is inserted into the stomach through the mouth of the
patient. The stomach is insufflated by blowing air into the stomach
through the endoscope. The insufflation brings the stomach in
apposition to the abdominal wall and allows for direct access from
the skin to the stomach of the patient.
An insertion site is located by surveying the interior of the
stomach with the endoscope. The endoscope is then used to
illuminate the selected insertion site in such a way that the light
of the endoscope is visible from outside of the patient's body
through the skin of the patient.
An incision is made at the place on the patient's skin indicated by
the light from the endoscope and at the corresponding location on
the exterior wall of the stomach. A cannula is then inserted
through the incision and a guide wire is inserted into the stomach
through the cannula. Graspers on the end of the endoscope grab hold
of the distal portion of the guide wire in the stomach and the
endoscope is withdrawn from the patient while the graspers hold the
guide wire. The guide wire is of sufficient length to allow a
proximal portion of it to extend out of the patient from the
cannula after the distal portion is withdrawn from the stomach and
through the patient's mouth by the endoscope.
The end of the guide wire extending out from the patient's mouth is
attached to the proximal end of the tube 1, which is drawn though
the mouth and esophagus and into the stomach of the patient by
pulling on the proximal end of the guide wire. The tube 1 is then
pulled through the incision in the stomach and skin of the patient
until only the distal end portion 17 and the inflation portion 2 of
the tube 1 remain inside of the stomach. Optionally, the tube 1 may
have a coned tip to help move the tube 1 through the incision in
the stomach. Optionally, a wire at the tip of the cone may be used
for pulling the tube 1 through the incision. Once the tube 1 is in
place, the coned tip may be cut off. The cannula is removed as the
proximal end 16 of the tube 1 is drawn through the incision in the
stomach, and is removed entirely when the proximal end 16 of the
tube 1 is disposed at the patient's skin. The inflation portion 2
of the tube 1 is then inflated by introducing fluid into the
inflation portion 2 through the inflation lumen 26. The inflated
inflation portion holds the tube 1 in place and the guide wire is
removed from the tube 1. A non-inflatable retention member such as
a flange 2' may be placed on the proximal end portion 16 of the
tube 1 to keep the tube 1 disposed at the patient's skin.
An alternate method of PEG known as push PEG may also be used to
insert the tube 1. The tube 1 is pushed through the incision in the
stomach and the skin of the patient until it is disposed as
described hereinabove with respect to the pull method.
A third method which may be used for inserting the tube 1 via PEG
is known as the Russell method. As with both the push method and
the pull method, the insertion site is located via endoscopy. An
incision is made in the skin and stomach and a guide wire is
inserted through the incision into the stomach via a cannula or
needle. A dilator (or introducer) with a peel away sheath is guided
along the guide wire and inserted into the stomach. After the
dilator (introducer) and sheath are inside the gastric lumen, the
dilator is removed and the tube 1 is inserted along the guide wire
and through the peel away sheath. The sheath is then peeled away
and the tube 1 is fixed in place.
The tube 1 may also be inserted without using an endoscope, for
example, through a procedure similar to insertion of feeding tubes
by Percutaneous Radiological Gastrostomy (PRG). According to PRG,
the stomach is insufflated via a nasogastric tube. Organs which may
be interposed between the stomach and the abdominal wall, such as
the colon, are excluded by CT scan or ultrasonography. Exclusion of
interposed organs may also be accomplished after insufflation by
fluoroscopy. The selection of the insertion site is also determined
by fluoroscopy or a similar method.
After the insertion site has been located, the tube 1 may be
inserted transabdominally as in the Russell method of PEG.
Alternatively, a guide wire may be inserted as in the endoscopic
pull method. The wire is then maneuvered through the stomach and
esophagus and out of the patient's mouth and is used to guide the
tube 1 back through the mouth, esophagus and stomach and out of the
insertion site (see, e.g., Mustafa N. Zmen et al. "Percutaneous
Radiologic Gastrostomy" European Journal of Radiology
43:186-95).
The tube 1 may be inserted surgically. One suitable surgical
technique that may be used to insert the tube 1 is the laparoscopic
method. In this method, after pneumoperitoneum has been created, a
5 mm trocar is used to grasp a site on the anterior stomach wall
that is appropriate for tube placement without excessive tension on
the stomach. A skin incision down to the rectus sheath is made. A
trocar is placed through the rectus sheath and the stomach wall is
grasped and pulled upwards. An incision is made in the stomach and
the tube 1 is inserted. Using the retention member at the distal
end portion 17 of the tube 1, the stomach is brought snugly against
the abdominal wall. The tissue is sutured around the tube 1. (see,
e.g., Andrew Luck et al. "Laparoscopic Gastrostomy: Towards the
Ideal Technique" Aust. N. Z. J. Surg. (1998) 68:281-283).
The tube 1 may be inserted in other portions of the upper digestive
system besides the stomach. For example, direct jejunostomy,
wherein a tube is inserted transabdominally into the jejunum, may
be accomplished through methods similar to those described
hereinabove with reference to gastrostomy tube placement. The
retention member of the device should generally be smaller for
jejunostomy procedures to avoid irritation of the jejunum or
obstruction of the jejunal lumen.
FIG. 1 illustrates an inflatable retention member, i.e. the
inflation portion 2, that is attached to the tube 1 to prevent the
tube 1 from falling out of the patient. FIGS. 1, 1A and 1B
illustrate two alternative non-inflatable retention members that
may be used in place of and/or in addition to the inflatable
portion 2. FIGS. 1 and 1A illustrate a flange 2' and FIG. 1B
illustrates a dome 2''. A flange 2' or dome 2'' that is located at
the distal end portion 17 of the tube 1 helps to prevent the tube 1
from coming out of the stomach 3 or other section of the upper
digestive system. A flange 2' or dome 2'' that is located at the
proximal end portion 16 of the tube 1 helps to prevent the tube
from falling into the patient's upper digestive system.
When an inflatable retention member is used, the tube 1 preferably
has an inflation lumen 26 so that the inflatable retention member
can be inflated. FIG. 1C shows a cross section of the tube 1 taken
perpendicular to the axis of tube 1. Inflation lumen 26 extends
from the inflation portion 2 to the proximal end portion 16 of the
tube 1 and is a pathway for introducing fluid, such as water or
air, to the inflation portion 2 from outside of the patient.
Removal lumen 25 extends from the proximal end portion 16 to the
distal end portion 17 of the tube 1 and is a pathway for the
removal of food from the stomach 3 or other part of the upper
digestive system of the patient. The inflation lumen 26 is
preferably minimal in size to allow the removal lumen 25 to be as
wide as possible within the tube 1. In the illustrated embodiment,
valves 15, 27 are provided in lumens 25, 26, respectively, as shown
in FIG. 7. With the non-inflatable retention members 2' and 2''
shown in FIGS. 1A and 1B, the second lumen 26 in tube 1 can be
eliminated.
Inflatable retention members are suitable for use with procedures
similar to the push method, while either inflatable or rigid
retention members are suitable for use with procedures similar to
the pull method. One example of a tube that has an inflatable
retention member is taught in Tiefenthal et al. (U.S. Pat. No.
6,506,179), the entire contents of which are incorporated herein by
reference. An alternative deformable retention member is taught in
Snow et al. (U.S. Pat. No. 6,077,250), the entire contents of which
are incorporated herein by reference.
Retention members that may be deformed in situ allow the tube 1 to
be removed without additional endoscopy. The retention member is
deflated or deformed and the tube 1 is pulled out using traction.
In cases where the retention member is rigid, the tube 1 may be cut
close to the skin and removed endoscopically.
It is preferable for the stomach to be positioned up against the
inner abdominal wall. This may be accomplished by insufflation
during the tube placement procedure and after the tube 1 has been
placed due to the retention member. For example, as shown in FIG.
1, retention members at the proximal end portion 16 and distal end
portion 17 of the tube 1 anchor the stomach up against the
abdominal wall. The stomach may also be anchored to the abdominal
wall by gastropexy, which may prevent complications arising from
tube placement and may facilitate the placement procedure. In
addition, jejunopexy is important injejunostomy procedures in order
to secure the jejunum during the tube placement procedure (see Zmen
et al., supra). For example, to secure the stomach or jejunum to
the abdominal wall, T-shaped metal or nylon fixing members may be
inserted trans-gastrically or trans-jejunally close to the tube
insertion site. The fixing members assume a T shape after insertion
and are tied near to the skin. Four fixing members are typically
disposed in a square pattern around the tube insertion site to
secure the stomach or jejunum. (see, e.g., F. J. Thornton et al.
"Percutaneous Radiologic Gastrostomy with and without T-Fastener
Gastropexy: a Randomized Comparison Study" Cardiovasc Intervent
Radiol. 2002 November-December; 25(6):467-71).
Reference is now made to various forms of pumps which are
attachable to the proximal end portion 16 of the tube 1. Any
conventional pump, the construction of which will be readily
understood to one skilled in the art, may be used. FIGS. 2 and 3,
for example, display pumps 8 and 9 which are attachable to the
proximal end portion 16 of the tube 1 for removal of food from the
stomach 3 or upper digestive system of the patient. It would be
suitable to use a pump that extracts more than 750 ml of food from
the upper digestive system of a patient within 30 minutes or less.
The pump may be operated intermittently to prevent tube collapse,
tube clogging or mucosal irritation. The pump may be manual or
battery operated. Optionally, a rechargeable power supply may be
incorporated into the pump, and the pump may be configured to be
carried on a patient's belt.
FIG. 2 depicts a manual bulb pump 8 that is attached to the
proximal end portion 16 of the tube 1 and is operated to remove
food from the patient's upper digestive system through the tube 1.
The manual bulb pump 8 preferably comprises silicone rubber or a
similar flexible material so as to permit the contents of the bulb
pump 8 to be evacuated by squeezing the bulbous end of the bulb
pump 8. The circumference of a tapered end essentially corresponds
to an interior circumference of the lumen 25 of the tube 1. To
operate the manual bulb pump 8, air is first evacuated from the
bulb pump 8 by squeezing the bulb, and then the tapered end of the
bulb pump 8 is inserted into the lumen 25 of the proximal end
portion 16 of the tube 1 so as to create a seal between the tapered
end and the tube 1. The bulb is then released to allow it to
re-inflate. The negative pressure in the bulb pump 8 (when it is
released) causes food to flow out from the upper digestive system
toward the proximal end portion 16 of the tube 1 and into the bulb
of the manual bulb pump 8. The bulb pump 8 is then disengaged from
the tube 1 and the removed food is evacuated from the bulb. The
cycle may be repeated until a desired amount of food is removed
from the upper digestive system of the patient.
FIG. 3 depicts another pumping arrangement in which a pump in the
form of a syringe 9 is attached to the proximal end portion 16 of
the tube 1 and is operated to remove food from the patient's upper
digestive system through the tube 1. The syringe 9 preferably
comprises a tapered end portion with an aperture at the distal end
thereof. The circumference of the tapered end portion 9a
corresponds to the interior circumference of the lumen 25 of the
tube 1. To operate the syringe 9 to remove food from the upper
digestive system of the patient, the contents (air or food) of the
syringe 9 are evacuated by depressing the plunger. The tapered end
portion 9a of the syringe 9 is inserted into the proximal end
portion 16 of the tube 1 so as to create a seal between the tapered
end portion 9a and the tube 1. The plunger of the syringe 9 is then
withdrawn so as to create negative pressure to draw food out from
the upper digestive system through the tube 1 and into the syringe
9. The syringe 9 is then disengaged from the tube 1 and evacuated
by, for example, depressing the plunger thereof. 60 cc is an
example of a suitable size for the syringe 9. The cycle may be
repeated until a desired amount of food is removed from the upper
digestive system of the patient.
The manual bulb pump 8 and syringe 9 may be activated by the
patient or by a health care provider at a predetermined time after
eating. The predetermined time is preferably set by a physician
and, for example, may be 20-30 minutes. A physician may also
determine a maximum volume of food to be removed from the upper
digestive system of the patient after each meal. The maximum volume
may be set in terms of a maximum number of pumping cycles which is
told to the patient or health care provider if the pump 8, 9 is
manually operated.
In a preferred embodiment, the pump that is used to extract food
from the patient's upper digestive system periodically reverses
direction and pumps air and/or water into the upper digestive
system of the patient during the periods of reverse operation. The
air and/or water helps to solubilize or breakdown the food in the
upper digestive system so that it can be pumped out easily. In
addition, the air and/or water helps prevent the tube 1 from being
suctioned up against the stomach wall while food is extracted from
the upper digestive out through the tube 1. For example, every
seven seconds of pumping may be followed by two seconds of reverse
operation.
FIG. 4 illustrates a variation of an embodiment of the present
invention in which the extracted food is evacuated from a pump 6
into a bag 12 that is attached to the pump 6. As shown in FIG. 4,
after the food is pumped out of the upper digestive system of the
patient by the pump 6, the food may be stored in a bag 12 that is
attachable to the proximal end portion of the pump 6. The bag 12
may be opaque, scented, biodegradeable and worn by the patient on a
belt or other strap. Alternatively, as shown in FIGS. 11 and 16,
the food may be pumped from the patient's upper digestive system
into the pump 6 and then into a tube 28 attached to the pump 6. The
contents of the tube 28 attached to the pump 6 may be emptied into
a toilet. The tube 28 may be opaque, scented, biodegradeable and
flushable down the toilet.
FIG. 5 illustrates a cleaning device being used to clean the tube 1
after food has been extracted from the patient's upper digestive
system through the tube 1. As shown in FIG. 5, the tube 1 may be
cleaned using a brush 14 that is adapted to clean the inside of the
tube 1. The pump 6, manual bulb pump 8 and syringe 9 may be cleaned
by flushing them with saline and/or a disinfectant solution after
use.
FIG. 6 illustrates a second embodiment of the present invention in
which a feeling of satiety is created in the patient by inflating
the balloon anchor. Creating a feeling of satiety curbs the
patient's hunger and desire to eat food thereby allowing the
patient to eat less and lose weight. As shown in FIG. 6, the
inflation portion 2, which is the retention member that holds the
tube 1 in the patient's stomach, also serves the function of
decreasing stomach capacity to create a feeling of satiety when it
is inflated. The inflation portion 2 may be variably inflated by
adding or removing fluid through the inflation lumen 26 of the tube
1 (shown in FIG. 1C).
FIG. 7 shows an axial cross sectional view of the tube 1 extending
out from the skin 5 of the patient in which the removal lumen 25
and the inflation lumen 26 are visible. In a feature which may be
incorporated into any of the various embodiments of the present
invention, a valve 15 is provided at the proximal end portion 16 of
the tube 1 in the removal lumen 25. The valve 15 ordinarily
prevents food from leaving the tube 1. The valve 15 is opened when
a pump is attached to the proximal end portion 16 of the tube 1.
For example, the tapered end portion of the manual bulb pump 8
(shown in FIG. 2) and the tapered end portion of the syringe 9
(shown in FIG. 3) each push open the valve 15 when they are
inserted into the proximal end portion 16 of the tube 1. When the
valve 15 is opened by the ends of the pumps, food can be removed as
described hereinabove. A cap 13 (shown in FIG. 1) is preferably
placed on the proximal end portion 16 of the tube 1 when a pump is
not attached. The cap 13 may be pressed onto the end of the tube 1,
threaded on the end of the tube 1, or may have projections which
are frictionally inserted into the ends of lumens 25, 26 to seal
them in a closed condition.
FIG. 7 also shows a valve 27 provided at the proximal end portion
16 of the tube 1 in the inflation lumen 26. The valve 27 prevents
the fluid used to inflate the inflation portion 2 from escaping the
inflation portion 2 through the inflation lumen 26. That is, the
valve 27 prevents the inflation portion 2 from deflating. If it
becomes necessary to deflate the inflation portion 2 to remove the
tube 1 from the upper digestive system of the patient, or to
further inflate the portion 2, a needle on a syringe may be
inserted into the inflation portion 26 so as to open the valve 27
by pushing the needle through the valve members. The fluid used to
inflate the inflation portion 2 may then be removed or added with
the syringe.
FIG. 8 illustrates a third embodiment of the present invention
showing a tube having two balloons attached to that portion of the
tube that is disposed within the patient's upper digestive system.
The balloon anchor 2 is expandable to about 10 ml and is positioned
up against the stomach wall to prevent the tube 1 from falling out.
The inflatable balloon 29 is expandable from about 100 ml to about
850 ml and may be expanded intermittently to limit the capacity of
the stomach. For example, the balloon 29 may be inflated via an
inflation lumen prior to a meal to create the sensation of being
full. After the meal, the balloon 29 may be deflated to prevent
chronic accommodation. An electrically or a manually operated pump
may be used to cause the inflation.
The tube 1 in this embodiment has a long inner tube length of about
10 cm or longer and a diameter of 28 French (9.3 mm) in size or
greater. The tube 1 may have multiple holes 32 in the sidewall of
its distal end portion 17 as shown in FIG. 8 and also in FIGS. 10
and 13-15B. The holes 32 may be 5.times.7 mm in size. The holes 32
provide non-vascular drainage from the patient. Preferably, the
holes 32 are arranged in a spiral pattern 1 cm to 1.5 cm apart
without losing structural integrity. More preferably, cushions or
bumpers (not shown) are located on the tube 1 and in between the
holes 32 to prevent the tube from being sucked up against the
stomach wall while food is extracted from the upper digestive
system out through the tube 1. For example, cushions or bumpers
that are raised 3-4 mm above the surface of the tube 1 may be used
for this purpose.
As shown in FIG. 8, a second retention member 33 may be attached at
the proximal end portion 16 of the tube 1 to keep the tube 1 fixed
to the abdominal surface. This second retention member may be
similar to the retention members described hereinabove and shown in
FIGS. 1, 1A, 1B and 6. The distance between the second retention
member 33 at the proximal end portion 16 of the tube 1 and the
balloon anchor 2 at the distal end portion 17 of the tube 1 can be
adjusted to account for the varying amount of intervening tissue
40, 40' as shown in FIGS. 15A and 15B. For example, the second
retention member 33 may be attached to the tube 1 via an
interference or friction fit. Specifically, the second retention
member 33 may be placed around the outer surface of the proximal
end portion 16 of the tube 1 and held in place on the tube 1 if it
has an inner diameter that is slightly smaller than the outer
diameter of the tube 1. As the patient loses weight, the proximal
end portion 16 of the tube 1 extends farther and farther away from
the patient's abdominal surface. A physician or the patient can
slide the second retention member 33 down towards the abdominal
surface and the excess amount of the tube 1 can be cut off.
FIG. 9 illustrates a fourth embodiment of the present invention
with a tube 1 having a curved configuration at its distal end
portion 17 and a plurality of holes 32 in a sidewall. As shown in
FIG. 9, the distal end portion 17 of the tube 1 is adapted to
assume a curved configuration when disposed in the upper digestive
system of a patient. Specifically, the distal end portion 17 of the
tube 1 is flexible to facilitate insertion and removal from the
patient. When the distal end portion 17 of the tube 1 is disposed
in the upper digestive system of the patient, it returns to its
natural curved configuration. The tube's tendency to return to its
natural curved configuration may be achieved, for example, by
bending the tube into a desired curved shape during the
manufacturing process before the tube has fully cured or cooled, or
by incorporating shape memory materials into the tube. As used
herein, the term "curved" includes flexed, bent, rounded, arched,
curled, coiled, spiral, and pigtail. This curved configuration is
preferable because it increases the intake area within the upper
digestive system. In addition, the coiled distal end portion 17 of
the tube 1 as shown in FIG. 10 helps to maintain the position of
the tube 1 within the patient's upper digestive system. The distal
end portion 17 of the tube 1 may, for example, be about 10 cm long
or longer to improve the intake of the food from the upper
digestive system. Retention members (not shown) similar to the ones
described in the above embodiments may also be used in this
embodiment.
In an alternative embodiment (not shown), an actuating mechanism is
configured to bend the distal end portion 17 of the tube 1 into a
curved configuration. The actuating mechanism may, for example, be
a string attached to the distal end portion 17 of the tube 1 that,
when retracted causes the tube to assume a curved configuration
(e.g. a loop with an arc that measures between about
270.degree.-360.degree.). A Cope Loop is a well known example of
this arrangement.
FIG. 10 illustrates a fifth embodiment of the present invention
showing a tube 1 having a curved configuration, multiple holes 32
in a sidewall, and a morcellation device 36 housed within a housing
37 at its distal end portion 17. Examples of morcellation devices
are disclosed in U.S. Pat. Nos. 5,618,296, 5,741,287 and 5,520,634,
herein incorporated by reference in their entirety. As shown in
FIG. 10, a morcellation device 36 is provided at the distal end
portion 17 of the tube 1 to divide and grind food into smaller
pieces as it enters the tube 1. The morcellation device 36 thus
allows large food to be removed from the patient without clogging
the tube 1. The morcellation device 36 can be, for example, a
mechanical propeller provided within a housing 37 at the distal end
portion 17 of the tube 1. The housing 37 is constructed to protect
body tissue from the morcellation device 36. In the illustrated
embodiment, the housing 37 has an opening to permit the entry of
food from the patient into the tube 1 and may, for example, be a
cage that surrounds the morcellation device 36 at the distal end
portion 17 of the tube 1. It is preferable that the housing 37 is
collapsible in both directions so that it can be easily inserted
into and taken out of the patient. The housing 37 is necessary to
prevent damage to the stomach.
FIG. 11 illustrates a feature that may be used with any embodiment
of the present invention in which the proximal end portion 16 of
the tube 1 lies substantially flush with the outer surface of the
patient's abdomen. This may be achieved by using ribbons attached
to the tube 1, for example at the internal retention member. The
ribbons are used to pull the tube 1 taut when the distal end
portion 17 of the tube 1 is disposed in the upper digestive system
of a patient. While the ribbons are pulled, the proximal end
portion 16 of the tube 1 is cut so that the proximal end portion 16
lies flush with the abdominal surface and a thin, hollow cylinder
with flanges is wedged onto the outside or inside surface of the
tube 1 via friction or by screwing it onto the tube 1 to retain the
tube 1 in its position and to keep it flush with the abdominal
surface. In alternative embodiments, the proximal end portion 16 of
the tube 1 may extend out past the abdominal surface by any desired
length (e.g., 1-10 inches).
FIG. 12 illustrates another feature that may be used with any
embodiment of the present invention in which a luer lock 34 is
utilized at the proximal end portion 16 of the tube 1. In this
embodiment, the pump 6 is attached to the tube 1 by screwing the
pump 6 onto the tube 1 around the external portion of the proximal
end portion 16 of the tube 1 rather than being inserted into the
tube 1. More specifically, the proximal end portion 16 of the tube
1 comprises concentric grooves or threads on the outside to
accommodate the pump 6, which prevents the pump 6 from reducing the
size of the removal lumen 25. Likewise, the pump 6 may have
corresponding concentric grooves or threads that allow it to
interact and connect with the luer lock 34. In this way, large
pieces of food can still be extracted out of the tube 1 because the
inner diameter of the tube 1 is not compromised or decreased due to
the pump 6 being inserted into the tube 1. Instead, the pump 6 is
coupled to or threaded onto the outside of the proximal end portion
16 of the tube 1.
FIG. 13 illustrates yet another feature that may be used with any
embodiment of the present invention in which the tube 1 has a
funnel shaped tip 35. The funnel tip is advantageous because it
facilitates the extraction of larger pieces of food into the tube 1
from the patient's digestive system.
FIG. 14 illustrates a sixth embodiment of the present invention
that has two intake tubes. In this embodiment, both of the intake
tubes 38 have a curved configuration and a sidewall with a
plurality of holes 32 located therein. Each intake tube 38
comprises a proximal end portion 39 and distal end portion 40. The
apparatus also comprises an output tube 41 having a proximal end
portion and a distal end portion 42. One or more retention members
(not shown) are preferably attached to the output tube 41 to
prevent the apparatus from coming out of the upper digestive
system. The plurality of intake tubes 38 are configured to be
disposed in the upper digestive system of the patient and the
output tube 41 is configured to pass through the patient's
abdominal wall when the plurality of intake tubes 38 are so
disposed. The distal end portion 42 of the output tube 41 is
operatively connected to the proximal end portion 39 of each of the
plurality of intake tubes 38 so that food can be extracted from the
upper digestive system of the patient through the distal end
portion 40 of each of the plurality of intake tubes 38 and out
through the proximal end portion of the output tube 41.
Optionally, pressure and/or flow sensors (not shown) may be placed
on and/or in the tube 1. Pressure sensors placed on the tube 1
inside and outside the stomach 3 may be used to estimate the
satiety of the patient. Alternatively or in addition to, flow
sensors that are placed inside the tube 1 may be used to calculate
the volume of food extracted through the tube 1.
Reference is now made to various methods for extracting food, for
limiting absorption of food, and for treating obese patients.
Installation of any of the above-described embodiments forms a
passageway into a patient's upper digestive system through the
patient's abdominal wall. The patient is allowed to carry out
his/her everyday affairs including ingesting food. After the
patient has ingested food, the food is extracted by pumping it out
of the upper digestive system through the passageway before it is
completely digested. This method and the others described below are
less invasive than the alternative surgical procedures for reducing
weight, are easy to perform, easy to reverse and have successfully
resulted in significant weight loss in obese patients.
In one method, a tube is positioned so that it passes through a
patient's abdominal wall into his/her upper digestive system. The
patient is allowed to go about his/her daily activities including
ingesting food. After the patient has ingested the food, the food
is extracted from the upper digestive system of the patient through
the tube. The patient may eat and extract the eaten food from
his/her upper digestive system through the tube repeatedly until a
desired weight loss is attained. The food that has been extracted
is not reintroduced into the patient. The tube may be kept in the
patient's upper digestive system for extended periods of time
(e.g., one month or more) while the eating/extracting is repeated
numerous times (e.g., 20 times or more) while the tube is in
place.
In a second method, a tube is positioned so that it passes through
the obese patient's abdominal wall into his/her upper digestive
system. The obese patient is allowed to go about his/her daily
activities including ingesting food. After the obese patient has
ingested the food, the food is extracted from the upper digestive
system of the obese patient through the tube. The obese patient may
eat and extract the eaten food from his/her upper digestive system
through the tube repeatedly until the obese patient has lost at
least 40 pounds. The food that has been extracted is not
reintroduced back into the obese patient.
In a third method, a tube is positioned so that it passes through a
patient's abdominal wall into the upper digestive system of the
patient whose gastrointestinal tract is unobstructed. The term
"unobstructed," as used herein, refers to a gastrointestinal tract
that is not mechanically obstructed and is also not functionally
obstructed. The patient is allowed to go about his/her daily
activities including ingesting food. After the patient has ingested
the food, the food is extracted from the upper digestive system of
the patient through the tube. The patient may eat and extract the
eaten food from his/her upper digestive system through the tube
repeatedly until a desired weight loss is attained. The tube may be
kept in the patient's upper digestive system for extended periods
of time (e.g., one month or more) while the eating/extracting is
repeated numerous times (e.g., 20 times or more) while the tube is
in place.
Preliminary trials in human patients have been successful. For
example, one female patient, middle aged and weighing 100 kilograms
(approximately 220 pounds), had a tube installed in her stomach for
59 weeks and successfully lost 38.45 kilograms (approximately 85
pounds) without experiencing any serious adverse side effects.
During the 59 weeks, the female patient aspirated after breakfast
and lunch meals daily. She consumed meals without any fluids over
approximately 30 minutes. At the end of the meal, she consumed 52
ounces of water in approximately 3-4 minutes. She waited
approximately 20 minutes after consuming the water before beginning
the extraction procedure. Accordingly, the patient uncapped the
tube, connected a 60 cc syringe to the tube and extracted food from
her stomach twice. This resulted in a siphon effect, which
permitted the subject to freely drain the stomach by allowing the
open tube to empty into a bucket. The patient squeezed the tube to
enhance propulsion and to break up large food. After draining
stopped, the patient usually drank another 52 ounces of water and
repeated the extraction procedure. She usually repeated this
procedure (drinking and extracting) about 2 more times, until she
felt her stomach was empty. The total amount of food extracted was
approximately 2-3 liters and the entire procedure took about 20
minutes. If resistance to extraction occurred during the procedure,
the patient flushed the tube with 30 cc of water. The water helped
to extract the food by dissolving it and by cleaning the
passageway. The patient changed her dietary intake to avoid tube
clogging. She avoided eating cauliflower, broccoli, Chinese food,
stir fry, snow peas, pretzels, chips, and steak. In addition, her
diet was supplemented with potassium. The chart below illustrates
her weight loss.
TABLE-US-00001 weight Week (kg) 0 100.9 2 96.8 3 96.8 4 94.7 4 94.7
5 94.0 7 93.6 8 90.9 9 92.9 10 92.7 11 90.4 12 89 13 89.3 14 88.6
15 87.7 16 86.5 17 86.5 18 86.3 19 85.9 20 83.9 21 82.9 22 81.6 23
80.45 24 79.7 25 78.6 26 78.6 27 77.2 28 78 29 76.2 30 76 31 75.2
31 77.1 32 76.4 33 76.4 34 76.4 35 74 36 74 37 74 38 73.6 39 73.5
40 73.2 41 72.6 42 71.22 43 69.5 44 69.8 45 69.45 46 68.45 47 66.6
48 65.5 49 65.5 50 65.5 51 65.2 52 65 53 65 54 64.5 55 64.8 56 64.8
57 63.8 58 63 59 62.45
It is noted that the food extraction apparatuses and methods
described above are preferably combined with a behavior
modification program that ideally educates patients in modifying
caloric intake, lifestyle and attitudes toward food. Learned
activities and support for weight loss may include activities such
as self-monitoring by recording food intake and physical activity,
avoiding triggers that prompt eating, assistance from family and
friends, problem solving skills and relapse prevention. The program
may be taught by an instructor or offered over the internet. In
addition, the program preferably includes a series of regular
check-ups by a health care provider. The check-ups ideally include
regularly testing blood for electrolytes, supplementing patients'
diets with vitamins, and administering medications to prevent
gallstone formation as needed. Ideally, the behavior modification
program will educate patients to change their lifestyle so as to
eliminate the need for food extraction.
The above described embodiments allow obese patients to lose weight
without undergoing drastic and invasive surgeries. As a result,
obese patients avoid many of the complications associated with such
surgeries. In addition, the present invention is easy to perform,
easy to reverse and allows obese patients to live a normal and
active lifestyle with fewer adverse side effects.
Additional advantages and modifications will readily occur to those
skilled in the art. For example, the features of any of the
embodiments may be used singularly or in combination with any other
of the embodiments of the present invention. In addition, the
insertion technique for placing the tube is not limited to known
gastrostomy techniques. Accordingly, various modifications may be
made without departing from the spirit or scope of the general
inventive concept as defined by the appended claims and their
equivalents.
* * * * *